Bydureon (generic: exenatide) is a prescription medicine that is used to treat type 2 diabetes. Bydureon is in a class of medications called incretin mimetics. It works by helping the pancreas to secrete insulin when blood sugar levels are high. It also decreases the amount of sugar that the liver produces and slows the emptying of the stomach.
Bydureon is an injectable prescription medicine used to treat adults with type 2 diabetes.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Bydureon can cause serious side effects, including:
- See "Drug Precautions".
- Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take Bydureon with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while you use Bydureon. Signs and symptoms of low blood sugar may include:
- fast heartbeat
- feeling jittery
- Kidney problems (kidney failure). Bydureon may cause nausea, vomiting or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away, or if you cannot drink liquids by mouth.
- Severe allergic reactions. Severe allergic reactions can happen with Bydureon. Stop taking Bydureon, and get medical help right away if you have any symptom of a severe allergic reaction.
The most common side effects of Bydureon include:
- itching at the injection site
- a small bump (nodule) at the injection site
Nausea is most common when you first start using Bydureon, but decreases over time in most people as their body gets used to the medicine.
Talk to your healthcare provider about any side effect that bothers you or does not go away.
These are not all the side effects of Bydureon. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Bydureon may affect the way some medicines work and some other medicines may affect the way Bydureon works.
Especially tell your healthcare provider if you take:
- other diabetes medicines, especially insulin or a sulfonylurea
- any medicine taken by mouth
- warfarin sodium (Coumadin, Jantoven)
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
Serious side effects may occur in people who take Bydureon, including:
- Thyroid Tumors
- Kidney problems
- stomach problems
- Severe allergy (hypersensitivity)
Do not use Bydureon if:
- you or any of your family members have a history of medullary thyroid cancer.
- you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body.
- you are allergic to exenatide or any of the ingredients in Bydureon. Symptoms of a severe allergic reaction may include:
- swelling of your face, lips, tongue, or throat
- problems breathing or swallowing
- severe rash or itching
- fainting or feeling dizzy
- very rapid heartbeat
Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using Bydureon.
Before using Bydureon, tell your healthcare provider if you:
- have medullary thyroid cancer
- have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- are allergic to any of the ingredients in Bydureon
- have severe problems with your stomach such as slow emptying of your stomach (gastroparesis) or problems digesting food.
- have or have had kidney problems, or have had a kidney transplant.
- have any other medical conditions.
Tell your doctor if you are pregnant or breastfeeding.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Tell your healthcare provider if you are pregnant or are planning to become pregnant. It is not known if Bydureon may harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Bydureon.
- Pregnancy Registry: Amylin Pharmaceuticals, Inc. has a registry for women who take Bydureon during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you take Bydureon at any time during pregnancy, you may enroll in this registry by calling 1-800-633-9081.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Bydureon passes into your breast milk. You and your healthcare provider should decide if you will take Bydureon or breastfeed. You should not do both without talking with your healthcare provider first.
Bydureon comes as a dry powder to be mixed with a liquid. Bydureon must be injected right after you mix it.
Bydureon is injected once every seven days (weekly) any time during the day, with or without meals.
Bydureon is a subcutaneous injection. You can take the injection in your stomach area (abdomen), your thigh, or the back of your upper arm. Each week you can use the same area of your body. But be sure to choose a different injection site in that area.
If you miss a dose of Bydureon, it should be taken as soon as you remember, provided the next regularly scheduled dose is due at least three days later. If the next dose is due one or two days later, skip the missed dose. Do not take 2 doses of Bydureon less than 3 days apart.
Take Bydureon exactly as prescribed. Follow the directions on your prescription label carefully.
The recommended dose of Bydureon is 2 mg injected once every seven days (weekly). The dose can be administered at any time of day, with or without meals.
If you take too much Bydureon, call your local Poison Control Center or seek emergency medical attention right away.
Active ingredient: exenatide
Inactive ingredients: polylactide-co-glycolide and sucrose.
Contents of liquid (diluent) in syringe:
Inactive ingredients: carboxymethylcellulose sodium, polysorbate 20, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, water for injection.
- Store Bydureon in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Do not use Bydureon past the expiration date. The expiration date is labeled EXP and can be found on the paper cover of the single-dose tray.
- Do not freeze Bydureon trays. Do not use Bydureon if it has been frozen.
- Protect Bydureon from light until you are ready to prepare and use your dose.
- If needed, you can keep your Bydureon tray out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks.
- See the Instructions for Use for information about how to throw away your used Bydureon parts.
Keep Bydureon, and all medicines, out of the reach of children.
WARNING: RISK OF THYROID C-CELL TUMORS
Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether Bydureon causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. Bydureon is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Bydureon. Patients should be counseled regarding the risk and symptoms of thyroid tumors